510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FZWClass I

Expander, Surgical, Skin Graft

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZW is the FDA product code for Expander, Surgical, Skin Graft, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
FZW
Device name
Expander, Surgical, Skin Graft
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
9

Clearances, product code FZW

By decision year
8 clearances under product code FZW with a decision year between 1987 and 2008, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FZW by decision year
YearClearances
19871
19881
19901
19911
19941
19971
19991
20081

Applicants with the most clearances

Product code FZW
Applicants holding the most 510(k) clearances under product code FZW
ApplicantClearances
Aesculap Inc1
Cox-Uphuff Intl.1
General Surgical Innovations1
Inamed Development Co.1
Lb Medical LLC1
Mentor1
Surgitek1
Wells Johnson Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order